GENERIC NAME OF THE MEDICINAL PRODUCT:

A. Clarithromycin for Injection BP 500mg (Bruxian)

QUALITATIVE AND QUANTITATIVE COMPOSITION:

A. Clarithromycin for Injection BP 500mg
Composition:
Each vial contains:
Clarithromycin IP…………………500mg
Lactobionic Acid BP………………q.s.
1 Ampoule contains:
Sterile Water for Injection IP…………10ml

THERAPEUTIC INDICATIONS:

Clarithromycin is used to treat certain bacterial infections, such as pneumonia (a lung infection), bronchitis (infection of the tubes leading to the lungs), and infections of the ears, sinuses, skin, and throat.

DIRECTION OF USE:

Shake vigorously with 10ml of sterile water for injection IP for 2-3 minutes to get clear solution before administration.

CAUTION AND SCHEDULE:

CAUTION: Not to be used if the reconstituted solution contains any visible particles.
The reconstituted solution should be used immediately or used within 24 hours when stored between 2°C to 8°C.
Warning: Use only Sterile Water for Injection IP for initial reconstitution. Sodium Chloride or any other diluents should not be used for initial reconstitution. If precipitates & solution will become hazy.
SCHEDULE: SCHEDULE H PRESCRIPTION DRUG-CAUTION: Not to be sold by retail without the prescription of a Registered Medical Practitioner.

STORAGE & DOSAGE:

STORAGE: Store below 25°C. Protect from light.
FLIP-OFF SEAL IS PROVIDED FOR TAMPER EVIDENCE
KEEP OUT OF REACH OF CHILDREN
Refer pack insert for further information.
DOSAGE: As directed by Physician.

Clarithromycin for Injection BP 500mg Technical Specification:

Product Name:Clarithromycin for Injection BP
Brand Name:Bruxian
Strength:500mg
Dosage Form:Lyophilized
Dry Powder for Solution for Injection/Infusion
Packing:1 Vial + WFI in a Tray
Route of Administration:For I.V. use only
Pack Insert/Leaflet:PIL (Patient Information Leaflet)
Documents:COA, MOA, Product Permission, Stability Studies, GMP
Therapeutic use:Antibiotic (Macrolide)
Indication: Clarithromycin is used to treat certain bacterial infections, such as pneumonia (a lung infection), bronchitis (infection of the tubes leading to the lungs), and infections of the ears, sinuses, skin, and throat.
Storage:Store below 25°C. Protect from light.

GENERIC NAME OF MEDICINAL PRODUCT:

  • Clarithromycin for Injection BP 500mg

QUALITATIVE AND QUANTITATIVE COMPOSITION:

  • Clarithromycin for Injection BP 500mg
    Composition:
    Each vial contains:
    Clarithromycin IP…………………500mg
    Lactobionic Acid BP………………q.s.
    1 Ampoule contains:
    Sterile Water for Injection IP…………10ml

THERAPEUTIC INDICATION:

Clarithromycin is used to treat certain bacterial infections, such as pneumonia (a lung infection), bronchitis (infection of the tubes leading to the lungs), and infections of the ears, sinuses, skin, and throat.

DIRECTION OF USE:

Shake vigorously with 10ml of sterile water for injection IP for 2-3 minutes to get clear solution before administration.

CAUTION AND SCHEDULE:

CAUTION: Not to be used if the reconstituted solution contains any visible particles.

The reconstituted solution should be used immediately or used within 24 hours when stored between 2°C to 8°C.

Warning: Use only Sterile Water for Injection IP for initial reconstitution. Sodium Chloride or any other diluents should not be used for initial reconstitution. If precipitates & solution will become hazy.

SCHEDULE: SCHEDULE H PRESCRIPTION DRUG-CAUTION: Not to be sold by retail without the prescription of a Registered Medical Practitioner.

STORAGE AND DOSAGE:

STORAGE: Store below 25°C. Protect from light.

FLIP-OFF SEAL IS PROVIDED FOR TAMPER EVIDENCE

KEEP OUT OF REACH OF CHILDREN

Refer pack insert for further information.

DOSAGE: As directed by Physician.